120 South State College Boulevard
Brea,
CA
92821
US
Posted: 06/27/2024
2024-06-27
2024-08-03
Job Category: Other
Job Number: 19332
Job Description
R&D Engineer
Location: Brea, CA - Hybrid, expectations are onsite M, T and TH with the availability to be in W & F if need be.
Summary:
- While maintaining a Customer Focus, responsibilities include (but are not limited to): Execution for Qualification of Medical Devices inclusive of Design Verification, Design Validation and Design Transfer activities.
- The R&D Engineer II will impact healthcare business groups by engaging in commercialization of new products and design changes for current products through development, qualification and launch phases.
- The R&D Engineer II contributes to building organizational effectiveness through creating, leveraging and sharing best practices; seeking and providing training; driving technical and workflow innovation.
This requires:
- Design control understanding and adherence
- Supporting Design Verification strategy development
- Supporting Desing Validation strategy development
- Creating, editing, and interpreting technical drawings
- Functional Device Testing
- Testing by Analysis
- End User Validation Testing
- Technical writing (protocols, reports, work instructions, presentations, etc.) and effective verbal communication
- Application of engineering principles for design / analysis
- Statistical analysis and sample plan development
Innovation
- Identifies external technologies
- Identifies critical strengths and weaknesses
- Nurtures IDR's (Invention Disclosure Records) from infancy
- Continuous Learning
- Participates in external activities to enhance the brand recognition of BD by writing papers and generating IP (Intellectual Property)
The R&D Engineer II will demonstrate and cultivate:
- Accountability: strong and clear accountability for the successful and timely achievement of goals.
- Ability to assess project / program needs, engage team members, build support, and execute; proactively identify and mitigate risks.
- Effective Communication:
- Hold and encourage frequent formal and informal communication within the team and the rest of the organization to ensure dissemination of important information.
- Recommendations to decision making committees
- Resolves conflicts within team by facilitating communication
- Strong interpersonal influence and persuasion skills; situational awareness; ability to persuade or be persuaded based on evidence with or without authority.
- Inclusive work environment:
- Promote and leverage diversity to achieve best outcomes.
- Decisiveness Despite Ambiguity:
- Developing agility and action orientated when facing change and uncertainty.
- Autonomously drives projects/deliverables.
Required Qualifications:
- Bachelors Degree in Mechanical or Biomedical Engineering with a min. of 3+ years of experience in medical device or other regulated industry OR Advanced Degree in Mechanical or Biomedical Engineering.
- Track record of technical problem solving and effective product development.
- Design controls expertise for Medical or regulated industry experience.
- Design Verification experience, (Protocol Generation, Report Writing, Testing Strategies)
- Proficient in statistical methods / tools
- Proficient in solid mechanics / mechanics of materials
- Familiarity with traditional and modern fabrication techniques
- Knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO14971 and ISO 80369 and collateral standards.
#LI-GD1
Share This Job:
Login to save this search and get notified of similar positions.
